Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria:
- Patients with vulvar cancer already enrolled onto Gynecologic Oncology Group
(GOG)-0244 who will undergo or have undergone definitive surgery for primary stage
I-IV vulvar cancer who will receive a radical vulvectomy or radical local excision
with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy;
- Patients who are going to receive multi-modality therapy (radiation +/-
chemotherapy) after undergoing surgery are eligible
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting
release of personal health information for GOG-0269 and for GOG-0244
- Patients may undergo sentinel node mapping as long as it is followed by a full
lymphadenectomy during the same operative event
- Serum Albumin level of >= 3.0 within 14 days of entry
- Patients with a GOG performance status of 0, 1, or 2
Exclusion Criteria:
- Patients not enrolled onto GOG-0244
- Patients with any prior clinical history of lower extremity lymphedema
- Patients who have a history of congestive heart failure, chronic renal disease, or
chronic liver disease
- Patients with a prior history of chronic lower extremity swelling
- Patients with a GOG Performance Grade of 3 or 4
- Patients with a history of other invasive malignancies if that malignancy included a
bilateral lymph node procedure (example: bilateral mastectomies and axillary
lymphadenectomies) or if their previous cancer treatment included any of the surgical
procedures
- Patients who have had prior lower extremity vascular surgery (arterial or venous)
- Patients who have had prior pelvic bilateral axillary or any pelvic, abdominal,
inguinal, or lower extremity radiation therapy
- Patients who are going to receive another elective surgery during the same operative
event as their inguinal lymphadenectomy and vulvar surgery
- Patients who undergo sentinel node biopsy without the intention of undergoing a
complete lymphadenectomy during that same operative event
- Patients with an implanted cardiac device such as a pacemaker or implantable
cardioverter defibrillator
- Patients who are pregnant or currently breastfeeding
- Patients who have been treated for, or are at risk of, bilateral arm lymphedema
- Patients with an allergic reaction to electrocardiogram (EKG) electrodes
- Patients who have had bilateral auxiliary dissection

OBJECTIVES:
I. To evaluate the sensitivity, specificity, and feasibility of bioimpedance technology as
compared to clinically derived measurements to include circumferential volumetric
measurements to detect lower-extremity lymphedema in patients who are undergoing an inguinal
lymphadenectomy during the concurrent surgical management of a vulvar cancer.
OUTLINE: This is a multicenter study.
Patients undergo preoperative and postoperative lower-extremity lymphedema assessment
comprising serial circumferential measurements, bioimpedance spectroscopy measurements, and
clinical evaluation using the Stemmer sign. Patients undergo radical vulvectomy or radical
local excision as prescribed by GOG-0244, and unilateral or bilateral inguinal or
inguinal-femoral lymphadenectomy.
After completion of study, patients are followed up at 4-6 weeks, every 3 months for 1 year,
and then every 6 months for 1 year.

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.

Call for more information

Request more information

Trial Details

Related Tags

A surgical procedure in which the lymph nodes are removed and a sample of tissue is checked under a microscope for signs of cancer. For a regional lymphadenectomy, some of the lymph nodes in the tumor area are removed; for a radical lymphadenectomy, most